FDA 510(k) Application Details - K002595

Device Classification Name Accessory, Assisted Reproduction

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510(K) Number K002595
Device Name Accessory, Assisted Reproduction
Applicant CRYO BIO SYSTEM
3722 AVE. SAUALITO
IRVINE, CA 92606 US
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Contact GABRIELE LINGENOLELE
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Regulation Number 884.6120

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Classification Product Code MQG
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Date Received 08/21/2000
Decision Date 11/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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